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Terminated

GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

FDA Recall Z-1790-2012 · Posted 2012-06-08

Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2006-05-31
Date Terminated2012-07-31
Product Quantity3,796 units

Reason for Recall

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

Firm Action

GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993090SILHOUETTE FCGe Medical Systems, Inc. · 1999-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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